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Electronic Sphygmomanometer (Model JN-163EW) is a home use digital monitor intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Electronic Sphygmomanometer is designed to measure the systolic and diastolic blood pressure of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
Measurement method to define systolic and diastolic pressure is similar to the Oscillometric method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. With a sensor, the microprocessor converts tiny alterations in cuff pressure to electrical signals and analyzes those signals to define the systolic and diastolic blood pressure and calculates heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".
The electronic sphygmomanometer achieves its function by a software. As the hardware includes an LCD, it can show the results of the blood pressure measurements and store 99 groups of data which can be checked and deleted.
The device is composed of a main unit and a cuff unit. The cuff unit, which is applicable to wrist circumference approximately between 13.5 and 19.5 cm, includes the inflatable bladder and shell. The main unit consists of the microprocessor, pressure sensor, pump, the electromagnetic deflation control valve and the battery. The subject device is powered by 2X AAA Lithium battery.

The provided document describes the 510(k) submission for the Electronic Sphygmomanometer (Model JN-163EW). This submission demonstrates the device's substantial equivalence to a predicate device and includes information about performance testing, including clinical trials.

However, the document does not provide the detailed acceptance criteria and a study that proves the device meets those criteria in the format requested. Specifically, it lacks:

• A table of specific quantitative acceptance criteria for blood pressure measurement accuracy (e.g., mean absolute difference, standard deviation) and the corresponding reported performance values for the subject device.
• Detailed information about the sample size, data provenance, ground truth establishment, expert qualifications, and adjudication methods for the clinical study.
• Information about MRMC studies or independent standalone algorithm performance.

The document states that clinical trials were performed according to ISO 81060-2:2019+A1:2020, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. This standard defines the methodology for clinically validating automated sphygmomanometers, including acceptance criteria. While the submission states that "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement," it does not present the results of this clinical trial against the acceptance criteria outlined in the standard.

Therefore, I cannot fully answer the request based on the provided text, as the specific performance data against defined acceptance criteria is missing. I can, however, extract what information is present regarding the clinical study and identify what is missing.

Based on the provided text, here is what can be inferred and what is explicitly missing regarding the acceptance criteria and study:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in a table. However, the document mentions that "The clinical trials for the Electronic Sphygmomanometers were performed according to the standard ISO 81060-2:2019+A1:2020." This ISO standard defines specific accuracy requirements for automated sphygmomanometers. For example, ISO 81060-2 typically requires:
  • Mean difference between the device and reference method to be within ±5 mmHg.
  • Standard deviation of the difference to be within 8 mmHg.
  • Specific percentages of measurements falling within ±5 mmHg, ±10 mmHg, and ±15 mmHg.
  • These apply to both systolic and diastolic blood pressure.
• Reported Device Performance: NOT PROVIDED IN THE DOCUMENT. The document states that performance testing was carried out and that the device meets "performance specifications for its intended use" and that "clinical tests" demonstrate effectiveness, but it does not provide the numerical results (e.g., mean difference, standard deviation) from the clinical study that would demonstrate it met the ISO 81060-2 criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document only states "relevant volunteers were collected." The specific number required by ISO 81060-2 is typically at least 85 subjects with sufficient blood pressure distribution across different ranges (hypertensive, normotensive, hypotensive). The document does not specify the actual number of subjects used in this study.
• Data Provenance: Not explicitly stated. Likely collected prospectively as it refers to "actual clinical trial." The country of origin of the data is not specified, but given the manufacturer is in China, it's plausible the study was conducted there.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Ground Truth Establishment: The ISO 81060-2 standard requires ground truth for blood pressure measurements to be established by two or more trained observers using a reference sphygmomanometer (e.g., mercury or an accepted equivalent).
• Number and Qualifications of Experts: The document does not specify the number of experts or their qualifications (e.g., trained clinicians, physicians) used for establishing the ground truth in this particular study.

4. Adjudication method for the test set:

• Adjudication Method: ISO 81060-2 typically involves multiple observers taking simultaneous measurements on the same subject. The standard specifies how the readings from these observers are to be handled (e.g., averaging of simultaneous readings from two independent observers, with a third observer if there's a significant discrepancy). The document does not explicitly state the adjudication method used, beyond the general reference to adherence to ISO 81060-2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is an Electronic Sphygmomanometer, which directly measures blood pressure. It is not an AI-based diagnostic imaging device that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This device is a standalone automated device. Its "algorithm" is the oscillometric method embedded in the device to calculate blood pressure. The clinical validation per ISO 81060-2 is effectively a standalone performance test, comparing the device's readings to standard reference measurements performed by human observers.

7. The type of ground truth used:

• The ground truth for blood pressure measurement, as per ISO 81060-2, is typically established through simultaneous auscultatory measurements performed by trained human observers using a reference sphygmomanometer (e.g., mercury or appropriately calibrated aneroid/electronic device). This is a highly controlled clinical measurement.

8. The sample size for the training set:

• Not Applicable/Not Provided. Electronic sphygmomanometers using the oscillometric method are based on established biophysical principles and do not typically involve a "training set" in the machine learning sense. Their internal algorithms are generally fixed based on these principles and extensive engineering validation, rather than being "trained" on a large dataset of patient measurements to learn patterns. If any internal parameters were optimized, the document does not mention it or the size of such a dataset.

9. How the ground truth for the training set was established:

• Not Applicable/Not Provided, for the same reasons as point 8.

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Infrared Forehead Thermometers (model2: JA-11S; model3: JA-11C) are non-sterile, reusable, noncontact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

Infrared Forehead Thermometers (model1: JA-11A; model2: JA-11S; model3: JA-11C) are hand-held, battery powered, Infrared Forehead Thermometers that covert a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an equivalent temperature when measuring from 1-3 cm of the subject's forehead with no contact.

It is composed of a probe, a display, two buttons (start button and power button), an enclosure and a battery cover.

It is used to measure human body temperature based on the relationship between temperature and measurable infrared radiation. Simply aim the unit's probe toward the surface to be measured to obtain a quick and accurate temperature.

When measuring body temperature, users need to measure in body mode from 1-3 cm from their forehead. Press the measuring key and then release it. The instrument will start measuring the target temperature. After about 1 second, the buzzer emits the corresponding alert sound, the measurement result is displayed on the LCD, and the backlight of the corresponding color is turned on. After about 3 seconds, the backlight is turned off, the unit symbol flashes, and the buzzer beeps shortly. Wait until the key is pressed to measure the temperature again. Start the thermometer without any operation, or no operation after temperature measurement, the thermometer will shut off and LCD go out with one short beep in 60 s ± 20 s.

It can store 32 sets of measurements. Press the 【M】button to cycle through them.

User contact components are the enclosure and keys. The materials of the components are ABS plastic.

The thermometer is for intermittent use.

The provided text describes information about an Infrared Forehead Thermometer (models: JA-11A, JA-11S, JA-11C) and its substantial equivalence submission to the FDA. The information focuses on the device's technical specifications, comparison to a predicate device, and the standards it conforms to for safety and effectiveness.

However, the document does not provide details about a study that proves the device meets specific acceptance criteria in the context of AI/machine learning performance, which is implied by several of your questions (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)"). This is a medical device clearance, not an AI/ML software clearance.

The "Clinical Accuracy Validation" section mentions that the device was tested per ASTM 1965-98, which is a standard for infrared thermometers. This standard typically defines the accuracy requirements for temperature measurement.

Therefore, I will extract the relevant performance criteria and reported performance for this non-AI medical device from the provided text. Many of your specific questions related to AI/ML studies cannot be answered from this document.

Acceptance Criteria and Device Performance for Infrared Forehead Thermometer

Based on the provided FDA 510(k) summary, the device's performance is demonstrated through adherence to relevant medical device standards, particularly related to temperature measurement accuracy and safety. The "acceptance criteria" here are the specifications outlined in the standards, and the "reported device performance" is the claim that the device conforms to these standards and their specified accuracy limits.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states: "ASTM 1965-98: Sample size, Patient population age, compared to reference thermometer, reference thermometer, designed per ASTM 1965-98: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature."

• Sample Size: The exact sample size for the clinical accuracy validation is not explicitly stated in this summary, other than referring to compliance with ASTM 1965-98 criteria for sample size.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies a clinical study was conducted as part of the ASTM 1965-98 validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (experts, qualifications) is not applicable to the performance testing described for this device. The ground truth for temperature measurement, as per ASTM 1965-98, typically involves comparison to a highly accurate reference thermometer (e.g., a blackbody radiator or a calibrated clinical standard thermometer) and direct patient measurements. It does not involve expert consensus in the way AI/ML diagnostic studies do.

4. Adjudication Method for the Test Set

This is not applicable as the test involves direct measurement against a reference standard, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not conducted and is not applicable to this device. This is a non-AI device for direct temperature measurement, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to AI algorithm performance. Not applicable as this is a non-AI device. The device's "standalone" performance is its direct measurement accuracy.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For temperature measurement validation according to ASTM 1965-98, the ground truth is typically established by:

• Highly accurate reference thermometers: Used in controlled laboratory settings (e.g., blackbody radiator) to test the device's accuracy at different temperature points.
• Simultaneous measurements with a clinically accepted reference thermometer: On human subjects to compare the device's reading to a trusted standard.

The specific details are not provided in this summary but are inherent in the referenced standard.

8. The Sample Size for the Training Set

This question relates to AI/machine learning model training. Not applicable, as this is a non-AI device.

9. How the Ground Truth for the Training Set was Established

This question relates to AI/machine learning model training. Not applicable, as this is a non-AI device.

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